Between the consequences of Brexit and a new commissioner at the FDA, executives across medtech are bracing for change within the global regulatory landscape. NxStage Medical‘s (NSDQ:NXTM) SVP of quality assurance, regulatory & clinical affairs, Todd Snell, spoke with MassDevice.com editor Sarah Faulkner about what he’s observing from his post at the Lawrence, Mass.-based company.
Faulkner: What has caught your eye from Scott Gottlieb’s first moves as head of the FDA?
Snell: I’m finding that there’s a real speed to FDA establishing alternative pathways for regulating software. In the past two weeks, FDA announced a program where companies can be part of a pilot where, if their inspection history and submission history is strong, the FDA may ‘pre-certify’ companies.
The intent here is to de-risk certain types of medical device software and hopefully provide a less burdensome pathway. I feel that’s a positive step out of the gate.
Faulkner: What are you keeping an eye on in the coming year in terms of regulatory policy?
Snell: One of my top priorities is to understand and plan for the European Medical Device Regulations along with Brexit. I’m very concerned that the number of Notified Bodies will start to decrease due to their increased legal responsibilities for the medical devices manufactured by their clients.
As the Notified Body pool potentially decreases I’m concerned that there will be difficulty in transitioning to the few Notified Bodies still operating in the future. On the other hand I believe it’s going to become more transparent and easier in the future to collaborate with FDA [compared to the European Union].
Faulkner: What are some best practices that companies should line themselves up for regulatory success?
Snell: I think it’s really about preparing for the clinical evidence required in the EU for existing products on the market and new product approvals.
We have already begun focusing on improving our clinical evaluations for the EU, which weren’t as heavily scrutinized in the past.
From a regulatory-clinical perspective, the increased scrutiny of clinical evidence in the EU may become the most costly and highest risk area for medical device manufacturers.
The need for a solid clinical strategy is critical going forward. We do very proactive post-market risk reviews of our products annually and look extensively into our clinical evidence and post-market experience and ask, “is the product doing what we intended it to do?”, “does our risk profile need to be updated?, and “is our clinical evidence sufficient?”
See Snell and other leading minds in medtech live at DeviceTalks Boston on Oct. 2.
